Model 4396 Left Ventricular (LV) Lead Chronic Performance Study

This study is currently recruiting participants.

Verified February 2013 by Medtronic Cardiac Rhythm Disease Management

Sponsor:

Information provided by (Responsible Party):

Medtronic Cardiac Rhythm Disease Management

ClinicalTrials.gov Identifier:

NCT01361685

First received: May 25, 2011

Last updated: February 1, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

May 25, 2011

Last Updated Date

February 1, 2013

Start Date ^ICMJE

May 2011

Estimated Primary Completion Date

February 2021 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Model 4396 LV Lead-related complication rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01361685 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Types of lead-related adverse device effects [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Percent of subjects with changes in electrode programming [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Number of fractures with and without loss of function [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Bipolar electrical performance at 1 year [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Bipolar pacing impedance [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Bipolar pacing capture threshold [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Model 4396 Left Ventricular (LV) Lead Chronic Performance Study

Official Title ^ICMJE

Attain Ability® Family Left Ventricular Lead Chronic Performance Study

Brief Summary

The purpose of this study is to evaluate long-term performance of the 4396 LV Lead. This evaluation is based on the number of lead-related complications occurring during the study compared to the number of leads enrolled in the study. The leads will be followed for 5 years after implant. This study is required by FDA as a condition of approval of the Model 4396 LV Lead. This study is part of the Product Performance Platform (PPP).

Detailed Description

Lead survivability will be summarized.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Patients implanted with a 4396 LV Lead within 30 days. All subjects must meet Inclusion criteria and none of the Exclusion criteria.

Condition ^ICMJE

Heart Failure

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

1016

Estimated Completion Date

May 2021

Estimated Primary Completion Date

February 2021 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Subject or appropriate legal guardian provides written informed consent and authorization for access to and use of health information (if applicable).
Complete implant and follow-up data, including Model 4396 lead-related events are available.

AND one of the following must apply:

Subject is within 30 days post-implant of a 4396 Model lead connected to a market released Cardiac Resynchronization Therapy (Cardiac Resynchronization Therapy-Pacemaker or Cardiac Resynchronization Therapy-Defibrillator) device. The Medtronic lead must be used for a pacing or sensing application.
Subject who participated in the Medtronic Attain Ability Model 4396 Left Ventricular Lead Pre-Market Study.

Exclusion Criteria:

Subject implanted at a non-participating site, and implant, follow-up data, including Model 4396 lead-related events are not available within 30 days from implant.
Subject who is, or will be inaccessible for follow-up at a study site.
Subject with exclusion criteria required by local law (Europe, Middle East or Africa only).

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Attain Ability Family LV Lead Chronic Performance Team

rs.systemlongevitystudy@medtronic.com

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT Number ^ICMJE

NCT01361685

Other Study ID Numbers ^ICMJE

4396 Chronic Performance

Has Data Monitoring Committee

Responsible Party

Medtronic Cardiac Rhythm Disease Management

Study Sponsor ^ICMJE

Medtronic Cardiac Rhythm Disease Management

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Medtronic Cardiac Rhythm Disease Management

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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